The RealStar® Ebolavirus RT-PCR Kit 1.0 is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from Ebolaviruses (such as Zaire ebolavirus, (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus) on specified instruments in EDTA plasma from individuals with signs and symptoms of Ebolavirus infection in conjunction with clinical and epidemiological risk factors.
· This test has not been FDA cleared or approved.
· This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories.
· This test has been authorized only for the detection of RNA from Ebolaviruses (such as Zaire ebolavirus, [including the Zaire ebolavirus strain detected in the West Africa outbreak 2014], Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus) and not for any other viruses or pathogens.
· This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Commissioner signature EUA Letter_medpdf
Fact Sheet for Health Care Providers_Ebolavirus.pdfpdf
Fact Sheet for Patients_Ebolavirus.pdfpdf
PM RealStar Ebolavirus RT-PCR Kit 1 0 EUA.pdfpdf